{"database": "openregs", "table": "documents", "is_view": false, "human_description_en": "where docket_id = \"FDA-2016-N-0124\" and posted_year = 2016 sorted by posted_date descending", "rows": [["FDA-2016-N-0124-0256", "FDA", "FDA-2016-N-0124", "Advice Letter from FDA CDER to American Chemistry Council", "Supporting & Related Material", "Letter", "2016-12-30T05:00:00Z", 2016, 12, null, null, "2016-12-30T18:09:27Z", null, 0, 0, "0900006482442593"], ["FDA-2016-N-0124-0213", "FDA", "FDA-2016-N-0124", "Safety and Effectiveness of Consumer Antiseptic Rub Products; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-07-19T04:00:00Z", 2016, 7, null, null, "2016-07-19T15:35:39Z", null, 0, 0, "09000064820cc4d9"], ["FDA-2016-N-0124-0069", "FDA", "FDA-2016-N-0124", "Reference 29-8 Kampf et al, Efficacy of ethanol based foams, 2010 re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:17:15Z", null, 0, 0, "09000064820750b2"], ["FDA-2016-N-0124-0196", "FDA", "FDA-2016-N-0124", "List of References re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T16:00:05Z", null, 0, 0, "0900006482079de4"], ["FDA-2016-N-0124-0206", "FDA", "FDA-2016-N-0124", "Econ Reference 10 \u2013 Johnston et al, The alcohol hand rub a good soap substitute re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T16:03:30Z", null, 0, 0, "0900006482079e34"], ["FDA-2016-N-0124-0165", "FDA", "FDA-2016-N-0124", "Reference 121 - FDA-1975-N-0012-0633 -Study 8 Volume 2 of 2 Gill M W et al Chronic Dietary Toxicity Oncogenicity Study re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:50:20Z", null, 0, 0, "09000064820755dd"], ["FDA-2016-N-0124-0172", "FDA", "FDA-2016-N-0124", "Reference 128- Loughlin et al, Pseudomonas Cells Adapted to BKC & Antibiotics re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:52:29Z", null, 0, 0, "09000064820755e5"], ["FDA-2016-N-0124-0173", "FDA", "FDA-2016-N-0124", "Reference 129 - Joynson et al, Adaptive Resistance to BKC & antibiotics re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:53:11Z", null, 0, 0, "09000064820755e6"], ["FDA-2016-N-0124-0179", "FDA", "FDA-2016-N-0124", "Reference 135 - Bevan et al, Two Generation Reproductive Toxicity Study with Isopropanol in Rats re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:54:47Z", null, 0, 0, "090000648207561a"], ["FDA-2016-N-0124-0180", "FDA", "FDA-2016-N-0124", "178 Reference 136 - McEvoy et al, The Effect of High Concentration Isopropanol on the Growth of a Solvent-Tolerant Strain of Chlorella vulgaris re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:55:03Z", null, 0, 0, "090000648207561b"], ["FDA-2016-N-0124-0195", "FDA", "FDA-2016-N-0124", "Reference 151 - Burleigh-Flayer et al, Isopropanol Vapor Inhalation Oncogenicity Study in Fisher 344 Rats and CD-1 Mice re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:59:42Z", null, 0, 0, "090000648207562c"], ["FDA-2016-N-0124-0113", "FDA", "FDA-2016-N-0124", "Reference 69 - Karatzas et al,  Salmonella and TCS resistance 2007 re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:33:46Z", null, 0, 0, "0900006482075516"], ["FDA-2016-N-0124-0132", "FDA", "FDA-2016-N-0124", "Reference 88 - NTP Toxicology and Carcinogenesis Studies of Benzethonium Chloride CAS 121-54-0 in F344N Rats and B6C3F1 Mice 1995 re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:40:36Z", null, 0, 0, "090000648207555b"], ["FDA-2016-N-0124-0015", "FDA", "FDA-2016-N-0124", "Reference 13 - 37 FR 9464, 1972,  Part 130 Procedure for classification of OTC drugs re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:00:58Z", null, 0, 0, "0900006482075449"], ["FDA-2016-N-0124-0037", "FDA", "FDA-2016-N-0124", "Reference 24-11 Prazuck et al. Reducing gastroenteritis occurences re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:07:41Z", null, 0, 0, "0900006482075474"], ["FDA-2016-N-0124-0046", "FDA", "FDA-2016-N-0124", "Reference 24-20 Lennel et al., Alcohol-based hand-disinfection reduced children\u2019s absence from Swedish day care centers re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:10:15Z", null, 0, 0, "090000648207547d"], ["FDA-2016-N-0124-0051", "FDA", "FDA-2016-N-0124", "Reference 24-25  Savolainen-Kopra et al., STOPFLU  is it possible to reduce number of days re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:11:41Z", null, 0, 0, "0900006482075486"], ["FDA-2016-N-0124-0111", "FDA", "FDA-2016-N-0124", "Reference 67 - FDA draft guidance for industry, Bioanalytical Method Validation  (Revision 1)September 2013 re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:33:12Z", null, 0, 0, "0900006482075514"], ["FDA-2016-N-0124-0112", "FDA", "FDA-2016-N-0124", "Reference 68 - Chuanchuen et al,  Triclosan cross-resistance in Pseudomonas 2001 re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:33:29Z", null, 0, 0, "0900006482075515"], ["FDA-2016-N-0124-0074", "FDA", "FDA-2016-N-0124", "Reference 30 - Briefing  NDAC 3-23-2005 re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:18:47Z", null, 0, 0, "09000064820750b7"], ["FDA-2016-N-0124-0075", "FDA", "FDA-2016-N-0124", "Reference 31 - Lennell et al, Alcohol based hand disinfection re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:19:08Z", null, 0, 0, "09000064820750b8"], ["FDA-2016-N-0124-0076", "FDA", "FDA-2016-N-0124", "Reference 32 - Comments from docket FDA-1975-N-0012 re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:19:37Z", null, 0, 0, "09000064820750b9"], ["FDA-2016-N-0124-0078", "FDA", "FDA-2016-N-0124", "Reference 34 - Pandejpong et al, Appropriate time-interval application of alcohol hand gel re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:20:18Z", null, 0, 0, "09000064820750cb"], ["FDA-2016-N-0124-0086", "FDA", "FDA-2016-N-0124", "Reference 42 - Ahn et al, In vitro Biologic Activities of the Antimicrobials TCC Its Analogs and TSC in Bioassay Screens re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:23:23Z", null, 0, 0, "09000064820750d3"], ["FDA-2016-N-0124-0096", "FDA", "FDA-2016-N-0124", "Reference 52 - Anway et al, Epigenetic Transgenerational Actions of Endocrine Disruptors re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:28:23Z", null, 0, 0, "09000064820750e8"], ["FDA-2016-N-0124-0103", "FDA", "FDA-2016-N-0124", "Reference 59 - ICH Guideline Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility S5R2 November 2005 re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:30:43Z", null, 0, 0, "09000064820750f7"], ["FDA-2016-N-0124-0016", "FDA", "FDA-2016-N-0124", "Reference 14 - FDA-1975-N-0012-0062 -- C4 Ref re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:01:16Z", null, 0, 0, "090000648207544a"], ["FDA-2016-N-0124-0044", "FDA", "FDA-2016-N-0124", "Reference 24-18 Yalcin et al.,Hand washing and adolescents.  A study from seven schools in KonyaTurkey re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:09:39Z", null, 0, 0, "090000648207547b"], ["FDA-2016-N-0124-0053", "FDA", "FDA-2016-N-0124", "Reference 24-27 Van Camp et al.,Hand sanitizer and rates of acute illness in military aviation personnel re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:12:23Z", null, 0, 0, "0900006482075488"], ["FDA-2016-N-0124-0085", "FDA", "FDA-2016-N-0124", "Reference 41 - FDA Guideline on OTC Sunscreen safety and effectiveness re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:22:55Z", null, 0, 0, "09000064820750d2"], ["FDA-2016-N-0124-0087", "FDA", "FDA-2016-N-0124", "Reference 44 - Crofton et al, Short-Term In Vivo Exposure to the Water Contaminant TCS re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:24:07Z", null, 0, 0, "09000064820750e0"], ["FDA-2016-N-0124-0088", "FDA", "FDA-2016-N-0124", "Reference 45 - Gee et al, Oestrogenic and Androgenic Activity of TCS and Breast Cancer Cells re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:24:26Z", null, 0, 0, "09000064820750e1"], ["FDA-2016-N-0124-0097", "FDA", "FDA-2016-N-0124", "Reference 53 - Bernal & Jirtle, Epigenetic Disruption - The Effects of Early Developmental Exposures re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:28:42Z", null, 0, 0, "09000064820750f1"], ["FDA-2016-N-0124-0105", "FDA", "FDA-2016-N-0124", "Reference 61 - FDA Guideline for Industry, M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:31:21Z", null, 0, 0, "09000064820750f9"], ["FDA-2016-N-0124-0003", "FDA", "FDA-2016-N-0124", "Reference 1 - Brown et al, Can alcohol Based Hand Rub Solutions Cause You to Lose your Driver's License re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T14:55:56Z", null, 0, 0, "09000064820752eb"], ["FDA-2016-N-0124-0009", "FDA", "FDA-2016-N-0124", "Reference 7 - FDA-1975-N-0012-0081 -- C12 Vol 1 and 2 6-13-1995 re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T14:58:09Z", null, 0, 0, "0900006482075443"], ["FDA-2016-N-0124-0010", "FDA", "FDA-2016-N-0124", "Reference 8 - Transcript of March 23, 2005 NDAC meeting re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T14:58:31Z", null, 0, 0, "0900006482075444"], ["FDA-2016-N-0124-0190", "FDA", "FDA-2016-N-0124", "Reference 146 - Martinez et al, A Comparison of the Absorption and Metabolism of Isopropyl Alcohol by Oral Dermal and Inhalation Routes re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:58:07Z", null, 0, 0, "09000064820759b8"], ["FDA-2016-N-0124-0169", "FDA", "FDA-2016-N-0124", "Reference 125 - Bore et al, Adapted Tolerance to BKC in Ecoli Studied by Transcriptome and Proteome Analyses re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:51:21Z", null, 0, 0, "09000064820755e1"], ["FDA-2016-N-0124-0170", "FDA", "FDA-2016-N-0124", "Reference 126 - Chuanchuen et al, Susceptibilities to Antimicrobials and Disinfectants in Salmonella Isolates Obtained from Poultry and Swine re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:51:49Z", null, 0, 0, "09000064820755e3"], ["FDA-2016-N-0124-0205", "FDA", "FDA-2016-N-0124", "Econ Reference 9 \u2013 Turner et al, Dermal absorption of isopropyl alcohol from a commercial hand rub implications for its use in hand decontamination re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T16:03:14Z", null, 0, 0, "0900006482079e33"], ["FDA-2016-N-0124-0118", "FDA", "FDA-2016-N-0124", "Reference 74 - Levy, Active Efflux a Common Mechanism for Biocide and Antibiotic Resistance re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:35:31Z", null, 0, 0, "0900006482075532"], ["FDA-2016-N-0124-0119", "FDA", "FDA-2016-N-0124", "Reference 75 - Russell, Do Biocides Select for Antibiotic Resistance re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:35:50Z", null, 0, 0, "0900006482075533"], ["FDA-2016-N-0124-0149", "FDA", "FDA-2016-N-0124", "Reference 105 - McDonnell, Alcohols re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:45:52Z", null, 0, 0, "0900006482075591"], ["FDA-2016-N-0124-0152", "FDA", "FDA-2016-N-0124", "Reference 108 - Benzalkonium safety in  CIR review re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:46:49Z", null, 0, 0, "0900006482075595"], ["FDA-2016-N-0124-0032", "FDA", "FDA-2016-N-0124", "Reference 24-6 Larson et al.,  Impact of non pharmaceutical interventions re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:06:18Z", null, 0, 0, "0900006482075465"], ["FDA-2016-N-0124-0042", "FDA", "FDA-2016-N-0124", "Reference 24-16 Gerald et al., Redesigning large school based trial re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:09:05Z", null, 0, 0, "0900006482075479"], ["FDA-2016-N-0124-0043", "FDA", "FDA-2016-N-0124", "Reference 24-17 Pandejpong et al, Appropriate time-interval application of alcohol hand gel re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:09:22Z", null, 0, 0, "090000648207547a"], ["FDA-2016-N-0124-0052", "FDA", "FDA-2016-N-0124", "Reference 24-26 Mott, P. J. et al., Alcohol-based instant hand sanitizer use in military settings a prospective cohort study of Army basic trainees re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:12:08Z", null, 0, 0, "0900006482075487"], ["FDA-2016-N-0124-0063", "FDA", "FDA-2016-N-0124", "Reference 29-2  Salmon et al , Health Care Workers  hand contamination, 2014 re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record", "Supporting & Related Material", "Background Material", "2016-06-30T04:00:00Z", 2016, 6, null, null, "2016-06-30T15:15:09Z", null, 0, 0, "090000648207549c"], ["FDA-2016-N-0124-0202", "FDA", "FDA-2016-N-0124", "Econ Reference 6 \u2013 Levy, Antibacterial Household Products Cause for Concern re Safety and Effectiveness of Consumer Antiseptics; 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